Generic, authorized generic of Amrix launched

PITTSBURGH — Drug maker Mylan has launched a generic treatment for muscle spasms, the company said Friday.

Mylan announced the launch of cyclobenzaprine hydrochloride, a once-daily muscle relaxant, in the 15-mg and 30-mg strengths. The drug is a generic version of Cephalon’s Amrix, which had sales of about $125 million during the 12-month period ended in March, according to IMS Health.

As the first company to file for Food and Drug Administration approval of a generic version of Amrix, Mylan will have 180 days of market exclusivity in which to compete directly with the branded version, under the provisions of the Hatch-Waxman Act of 1984, the law that created a regulatory approval pathway for generic pharmaceutical drugs.

In related news, Watson subsidiary Watson Pharma has launched an authorized generic of Amrix in the 15-mg and 30-mg strengths, as part of an agreement with Anesta AG, a subsidiary of Cephalon. Under the terms of the nonexclusive sales agent agreement, Anesta manufactures and supplies Watson with all dosage strengths of the authorized generic product.

Victrelis approved by FDA as chronic hepatitis C treatment

SILVER SPRING, Md.— The Food and Drug Administration has approved a new treatment for chronic hepatitis C, the agency said Friday.

The FDA announced the approval of Merck’s Victrelis (boceprevir) for patients with the disease. The drug is designed for patients who still have some liver function and have not previously received treatment for chronic hepatitis C infection or have failed previous treatments. The drug is approved for use in combination with the generic drug ribavirin and pegylated interferons, biotech drugs used for treating the disease.

“Victrelis is an important new advance for patients with hepatitis C,” FDA Office of Antimicrobial Products director Edward Cox said. “This new medication provides an effective treatment for a serious disease and offers a greater chance of cure for some patients’ hepatitis C infection compared to currently available therapy.”

ALEXANDRIA, Va. — The National Association of Chain Drug Stores announced on Friday that it sent a letter to the White House Office of National Drug Control Policy in support of the administration’s strategy to prevent and reduce prescription drug diversion and misuse. Last month, the administration released its report, "Epidemic: Responding to America’s Prescription Drug Abuse Crisis," detailing its policy recommendations.

"We appreciate the Obama administration’s recently released plan for responding to the current prescription drug abuse crisis, and would like to voice our support for the administration’s plan," NACDS wrote. The letter emphasized the highly beneficial uses of prescription medications, and highlighted ways in which pharmacists partner with patients to assist them with the appropriate use of prescription medications, and to help them adhere to their medication therapies.

"Pharmacists are uniquely qualified to provide medication therapy management services to patients, which help ensure that patients are prescribed the correct medications and that they are taking them properly," NACDS wrote.

In addition to providing patient care, chain pharmacies also partner with law enforcement and participate in state-run prescription drug monitoring programs, which work to help reduce prescription drug diversion and "doctor shopping" — seeking prescriptions from multiple physicians at the same time.

"We support the administration’s plans to enhance and increase utilization of these [PMP] programs among prescribers and to provide federal, state and local officials with the resources they need to utilize these tools to the maximum benefit," NACDS wrote.

NACDS emphasized the importance of protecting patient health and safety and the security of the prescription drug supply chain by maintaining a separation between prescription drug dispensing locations and drug take-back locations. NACDS expressed its prior support for a Drug Enforcement Administration-sanctioned prescription mail-back program.

Along with providing pharmacy’s support for the administration’s strategy to combat and prevent prescription drug diversion and misuse, NACDS indicated that it also used the comment letter to thank the Food and Drug Administration for its step-wise approach to its Risk Evaluation and Mitigation Strategy for opioids, which incorporated pharmacy’s concerns.

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